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Molecule

Elapegademase

Available on requestBiologicOrphanCold chain
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Elapegademase is a prescription medicine indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. It is available as injection for intramuscular use. MedsAcross supplies Elapegademase for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
5 October 2018
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intramuscular
Dosage forms
Injection
Biologic
Yes
Identifiers
UNII 9R3D3Y0UHSCAS 1709806-75-6DrugBank DB14712Q65087024

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

REVCOVI is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. REVCOVI is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

Source: US FDA prescribing information

How it works

SCID associated with a deficiency of ADA enzyme is a rare, inherited, and often fatal disease. ADA enzyme is involved in purine metabolism, catalyzing the irreversible hydrolytic deamination of adenosine or deoxyadenosine to inosine or deoxyinosine, respectively, as well as several naturally occurring methylated adenosine compounds. Maintaining a low level of 2'-deoxyadenosine and adenosine is crucial for proper number and function of immune cells as well as decreasing the frequency of opportunistic infections. Elevated adenosine levels, as occurring in ADA deficiency, contribute to apoptosis and a block in the differentiation of thymocytes, causing severe T‑lymphopenia. Elapegademase-lvlr provides an exogenous source of ADA enzyme that is associated with a decrease in toxic adenosine and deoxyadenosine nucleotides levels as well as an increase in lymphocyte number.

Source: US FDA prescribing information

Dosing overview

Patients transitioning from Adagen to REVCOVI: The starting dose of REVCOVI is 0.2 mg/kg weekly, intramuscularly. See Full Prescribing Information (FPI) for conversion formula from Adagen to REVCOVI. Adagen-naïve patients: The starting dose of REVCOVI is 0.4 mg/kg weekly based on ideal body weight or actual weight whichever is greater, divided into two doses (0.2 mg/kg twice a week), intramuscularly. For complete information, maintenance dosing and therapeutic monitoring, see FPI. REVCOVI is for intramuscular injection only. See FPI for administration instructions.

Source: US FDA prescribing information

Warnings and precautions

Injection Site Bleeding in Patients with Thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia, should not be used if thrombocytopenia is severe. Delay in Improvement of Immune Function: Protect immune deficient patients from infections until improvement in immune function.

Source: US FDA prescribing information

Storage

Store REVCOVI in the refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Elapegademase, sorted by availability.

MedicineManufacturerRegisterAvailability
Revcovi 2.4 mg/1.5 mL injectionIntramuscular Cold chainChiesiUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 5 October 2018Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Elapegademase available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Elapegademase and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Elapegademase have?

The catalogue lists 1 brand names for Elapegademase, including Revcovi.

Is Elapegademase approved by the US FDA?

Yes. The US FDA first approved Elapegademase on 5 October 2018, according to Drugs@FDA.

Does Elapegademase need cold chain shipping?

At least one listed presentation of Elapegademase must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. Revcovi prescribing information (Chiesi). U.S. National Library of Medicine, DailyMed. Retrieved 31 May 2026

Request Elapegademase for export supply

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